The study of effect of total anthocyanin base standardized (cornus mas L.) fruit extract on liver function, tumor necrosis factor α, malondealdehyde and adiponectin in patients with non-alcoholic fatty liver.
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General information
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The secondary outcomes along with a new ethic code were added to the protocol.
The secondary outcomes along with a new ethic code were added to the protocol.
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پیامدهای ثانویه همراه با کد اخلاق جدید به پروتکل اضافه گردید.
پیامدهای ثانویه همراه با کد اخلاق جدید به پروتکل اضافه گردید.
Ethics committees
#1
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2021-05-03, 1400/02/13
2021-05-03 00:00:00
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IR.SSU.SPH.REC.1400.020
IR.SSU.SPH.REC.1400.020
Secondary outcomes
#1
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Lipid accumulation product
Lipid accumulation product
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شاخص Lipid accumulation product
شاخص Lipid accumulation product
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Before and after the 12-week intervention
Before and after the 12-week intervention
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قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
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Formula
Formula
empty
فرمول
فرمول
#2
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Atherogenic index of plasma
Atherogenic index of plasma
empty
شاخص Atherogenic index of plasma
شاخص Atherogenic index of plasma
empty
Before and after the 12-week intervention
Before and after the 12-week intervention
empty
قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
Formula
Formula
empty
فرمول
فرمول
#3
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Atherogenic coefficient
Atherogenic coefficient
empty
شاخص Atherogenic coefficient
شاخص Atherogenic coefficient
empty
Before and after the 12-week intervention
Before and after the 12-week intervention
empty
قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
Formula
Formula
empty
فرمول
فرمول
#4
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Castelli 1 index
Castelli 1 index
empty
شاخص کاستلی 1
شاخص کاستلی 1
empty
Before and after the 12-week intervention
Before and after the 12-week intervention
empty
قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
Formula
Formula
empty
فرمول
فرمول
#5
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Castelli 2 index
Castelli 2 index
empty
شاخص کاستلی 2
شاخص کاستلی 2
empty
Before and after the 12-week intervention
Before and after the 12-week intervention
empty
قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
Formula
Formula
empty
فرمول
فرمول
#6
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TyG index
TyG index
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شاخص TyG
شاخص TyG
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Before and after the 12-week intervention
Before and after the 12-week intervention
empty
قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
Formula
Formula
empty
فرمول
فرمول
#7
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Fatty liver index
Fatty liver index
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شاخص Fatty liver index
شاخص Fatty liver index
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Before and after the 12-week intervention
Before and after the 12-week intervention
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قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
Formula
Formula
empty
فرمول
فرمول
#8
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Hepatic steatosis index
Hepatic steatosis index
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شاخص Hepatic steatosis index
شاخص Hepatic steatosis index
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Before and after the 12-week intervention
Before and after the 12-week intervention
empty
قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
Formula
Formula
empty
فرمول
فرمول
#9
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Visceral adiposity index
Visceral adiposity index
empty
شاخص Visceral adiposity index
شاخص Visceral adiposity index
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Before and after the 12-week intervention
Before and after the 12-week intervention
empty
قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
Formula
Formula
empty
فرمول
فرمول
#10
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NAFLD-liver fat score
NAFLD-liver fat score
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شاخص NAFLD-liver fat score
شاخص NAFLD-liver fat score
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Before and after the 12-week intervention
Before and after the 12-week intervention
empty
قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
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Formula
Formula
empty
فرمول
فرمول
#11
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estimated glucose infusion rate
estimated glucose infusion rate
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شاخص estimated glucose infusion rate
شاخص estimated glucose infusion rate
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Before and after the 12-week intervention
Before and after the 12-week intervention
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قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
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Formula
Formula
empty
فرمول
فرمول
#12
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Gamma glutamyl transpeptidase
Gamma glutamyl transpeptidase
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گاما گلوتامیل ترانس پپتیداز
گاما گلوتامیل ترانس پپتیداز
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Before and after the 12-week intervention
Before and after the 12-week intervention
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قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
By autoanalyzer
By autoanalyzer
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بوسیله اتوآنالایزر
بوسیله اتوآنالایزر
#13
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Serum levels of E-selectin
Serum levels of E-selectin
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سطوح سرمی ای سلکتین
سطوح سرمی ای سلکتین
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Before and after the 12-week intervention
Before and after the 12-week intervention
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قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
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By ELISA method
By ELISA method
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بوسیله روش الایزا
بوسیله روش الایزا
#14
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Serum levels of Asymmetric dimethylarginine
Serum levels of Asymmetric dimethylarginine
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سطوح سرمی دی متیل آرژینین نامتقارن
سطوح سرمی دی متیل آرژینین نامتقارن
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Before and after the 12-week intervention
Before and after the 12-week intervention
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قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
By ELISA method
By ELISA method
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بوسیله روش الایزا
بوسیله روش الایزا
#15
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Serum levels of nitric oxide
Serum levels of nitric oxide
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سطوح سرمی نیتریک اکساید
سطوح سرمی نیتریک اکساید
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Before and after the 12-week intervention
Before and after the 12-week intervention
empty
قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
By ELISA method
By ELISA method
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بوسیله روش الایزا
بوسیله روش الایزا
#16
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Seum levels of C reactive protein
Seum levels of C reactive protein
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سطوح سرمی پروتئین واکنشگر C
سطوح سرمی پروتئین واکنشگر C
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Before and after the 12-week intervention
Before and after the 12-week intervention
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قبل و بعد از 12 هفته مداخله
قبل و بعد از 12 هفته مداخله
empty
By ELISA method
By ELISA method
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بوسیله روش الایزا
بوسیله روش الایزا
Protocol summary
Study aim
Objective: evaluating the effect of total anthocyanin base standardized (cornus mas L.) fruit extract on liver function, tumor necrosis factor α, malondealdehyde and adiponectin in patients with non-alcoholic fatty liver (NAFLD).
Design
Patients are randomly assigned into 2 groups (n=40 in each group) using a software to receive total anthocyanin base standardized (cornus mas L.) fruit extract (equal to 320 mg/d anthocyanins) or placebo daily for 12 weeks.
Settings and conduct
In a randomized double-blind clinical trial, 80 patients with NAFLD will be recruited from Diabetes Research Center, Shahid Sadoughi university of medical sciences, Yazd. The subjects are randomly divided into two groups to take total anthocyanin base standardized (cornus mas L.) fruit extract or placebo.
Participants/Inclusion and exclusion criteria
Study population: patients with NAFLD (n=80).
Inclusion criteria: ALT levels more than 30 U / L in men and more than 19 U / L in women, age 25-26 years, the patients with grade 1, 2 and 3 fatty liver, the consent of subject to participate in the study, the patients are from Yazd.
Exclusion criteria: The history of diseases including cirrhosis, viral hepatitis, cardiovascular disease, diabetes, Wilson and cancer; Consumption of medications including corticosteroids, nonsteroidal anti-inflammatory drugs, hypoglycemic agents, tamoxifen, sodium valproate, methotrexate, probiotics, any medicine or supplement that affect liver function, supplements with antioxidant and anti-inflammatory properties; Following a special diet; Pregnancy and breastfeeding; Alcohol consumption.
Intervention groups
Intervention group with total anthocyanin base standardized (cornus mas L.) fruit extract or placebo group.
Main outcome variables
Liver function (liver enzymes and cytokeratin-18 levels, liver steatosis and fibrosis); tumor necrosis factor α, malondealdehyde and adiponectin levels.
General information
Reason for update
The secondary outcomes along with a new ethic code were added to the protocol.
Acronym
IRCT registration information
IRCT registration number:IRCT20180419039359N1
Registration date:2018-09-30, 1397/07/08
Registration timing:prospective
Last update:2021-10-03, 1400/07/11
Update count:2
Registration date
2018-09-30, 1397/07/08
Registrant information
Name
Zohreh Sadat Sangsefidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
sangsefidiz@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The study of effect of total anthocyanin base standardized (cornus mas L.) fruit extract on liver function, tumor necrosis factor α, malondealdehyde and adiponectin in patients with non-alcoholic fatty liver.
Public title
The study of effect of total anthocyanin base standardized (cornus mas L.) fruit extract in patients with non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ALT levels more than 30 U / L in men and more than 19 U / L in women
Age 25-26 years
Diagnosis of the disease by ultrasonography and by a gastroenterologist
The patients with grade 1, 2 and 3 fatty liver
The consent of subject to participate in the study
The patients are from Yazd
Exclusion criteria:
The history of diseases including cirrhosis, viral hepatitis, cardiovascular disease, diabetes, Wilson and cancer.
Consumption of medications including corticosteroids, nonsteroidal anti-inflammatory drugs, hypoglycemic agents or any medicine that affect blood glucose, tamoxifen, sodium valproate, methotrexate, probiotics, any medicine or supplement that affect liver function, supplements with antioxidant and anti-inflammatory properties (such as vitamin D, vitamin E, omega-3, resveratrol) during 1 month before the study
Following a special diet during 1 month before the study
Pregnancy and breastfeeding
شlcohol consumption
Age
From 25 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using Random allocation software. Also, randomization is stratified by age gender.
Blinding (investigator's opinion)
Double blinded
Blinding description
The products ((cornus mas L.) fruit extract and placebo) are packed in the bottles that are same in terms of color, shape and size and labeled with "A" and "B" by an outside person who dose not know the details of the study. Therefore, participants and researchers will not be aware of the nature of the products in bottles.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences ,Alam Square.
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.SSU.SPH.REC.1396.171
2
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences ,Alam Square.
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2021-05-03, 1400/02/13
Ethics committee reference number
IR.SSU.SPH.REC.1400.020
Health conditions studied
1
Description of health condition studied
non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Serum levels of Alanine Aminotransferase (ALT)
Timepoint
Before and after the 12-week intervention
Method of measurement
By autoanalyzer
2
Description
Serum levels of Aspartate Aminotransaminase (AST)
Timepoint
Before and after the 12-week intervention
Method of measurement
By autoanalyzer
3
Description
Serum levels of Tumor necrosis factor α (TNF-α)
Timepoint
Before and after the 12-week intervention
Method of measurement
By ELISA kit
4
Description
Serum levels of Malondealdehyde (MDA)
Timepoint
Before and after the 12-week intervention
Method of measurement
By ELISA kit
5
Description
Serum levels of adiponectin
Timepoint
Before and after the 12-week intervention
Method of measurement
By ELISA kit
6
Description
Serum levels of cytokeratin-18 fragment M30 (CK-18 M30)
Timepoint
Before and after the 12-week intervention
Method of measurement
By ELISA kit
7
Description
Liver steatosis
Timepoint
Before and after the 12-week intervention
Method of measurement
By ultrasonography
8
Description
Liver fibrosis
Timepoint
Before and after the 12-week intervention
Method of measurement
By fibroscan
Secondary outcomes
1
Description
Fasting blood glucose (FBS)
Timepoint
Before and after the 12-week intervention
Method of measurement
By autoanalyzer
2
Description
Serum levels of Triglyceride (TG)
Timepoint
Before and after the 12-week intervention
Method of measurement
By autoanalyzer
3
Description
Serum levels of High-density lipoprotein (HDL)
Timepoint
Before and after the 12-week intervention
Method of measurement
By autoanalyzer
4
Description
Serum levels of Low-density lipoprotein (LDL)
Timepoint
Before and after the 12-week intervention
Method of measurement
By autoanalyzer
5
Description
Serum levels of total cholesterol
Timepoint
Before and after the 12-week intervention
Method of measurement
By autoanalyzer
6
Description
Serum levels of insulin
Timepoint
Before and after the 12-week intervention
Method of measurement
By ELISA kit
7
Description
Insulin resistance
Timepoint
Before and after the 12-week intervention
Method of measurement
By HOMA-IR and QUICKI
8
Description
Lipid accumulation product
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
9
Description
Atherogenic index of plasma
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
10
Description
Atherogenic coefficient
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
11
Description
Castelli 1 index
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
12
Description
Castelli 2 index
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
13
Description
TyG index
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
14
Description
Fatty liver index
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
15
Description
Hepatic steatosis index
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
16
Description
Visceral adiposity index
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
17
Description
NAFLD-liver fat score
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
18
Description
estimated glucose infusion rate
Timepoint
Before and after the 12-week intervention
Method of measurement
Formula
19
Description
Gamma glutamyl transpeptidase
Timepoint
Before and after the 12-week intervention
Method of measurement
By autoanalyzer
20
Description
Serum levels of E-selectin
Timepoint
Before and after the 12-week intervention
Method of measurement
By ELISA method
21
Description
Serum levels of Asymmetric dimethylarginine
Timepoint
Before and after the 12-week intervention
Method of measurement
By ELISA method
22
Description
Serum levels of nitric oxide
Timepoint
Before and after the 12-week intervention
Method of measurement
By ELISA method
23
Description
Seum levels of C reactive protein
Timepoint
Before and after the 12-week intervention
Method of measurement
By ELISA method
Intervention groups
1
Description
Intervention group: Daily intake of total anthocyanin base standardized (cornus mas L.) fruit extract (equal to 320 mg/d anthocyanins) for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Daily intake of placebo for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center, Shahid Sadoughi university of medical sciences, Yazd, Iran
Full name of responsible person
Dr. Saeed Hossein Khalilzadeh
Street address
Diabetes Research Center, Alley of Art Hall, Beginning of Bahonar Square to Azadi Square, Shahid Sadoughi Boulevard
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3728 0226
Email
drc@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
masoud_mirzaei@hotmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zohreh Sadat Sangsefidi
Position
Ph.D. candidate on nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 353820910014
Fax
+98 35 3820 9119
Email
sangsefidi.zsadat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hassan Mozaffari-Khosravi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 353820910014
Fax
+98 35 3820 9119
Email
mozaffari.kh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zohreh Sadat Sangsefidi
Position
PhD candidate on Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Fax
+98 35 3820 9119
Email
sangsefidi.zsadat@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available